MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. GLENOID REAM BIT L; BIT, DRILL

Catalog Number	RMB-0990-818-03
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a total shoulder arthroplasty, the tip of two (2) glenoid ream bit l fractured off when the surgeon was reaming the glenoid.The procedure was resumed, after a non-significant delay, with the same device (when the second reamer fractured).The patient was not harmed as a consequence of this problem.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
The associated devices were returned and evaluated.The visual inspection revealed the instruments had some signs of wear consistent with normal use of the device.This included nicks and scratches along the reamer bit cutting edges, and scratches wrapping along the reamer bit shaft.The complaint alleges that the tips glenoid reamer bits were fractured off when the surgeon was reaming the glenoid.Visual evaluation did not identify signs of a fracture on the devices.A functional evaluation performed on the device revealed the ball joints on each device were jammed and unable to move freely.The devices are unable to be taken apart so an internal fracture cannot be determined at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.These devices are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GLENOID REAM BIT L
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19029433
• Report Number: 3002788818-2024-00051
• Device Sequence Number: 7338745
• Product Code: HTW
• UDI-Device Identifier: 00885556811641
• UDI-Public: 885556811641
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RMB-0990-818-03
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown